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MIRA Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine Analog

Monday, September 22, 2025 BiopharmaWatch Research 1 min read
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Key Takeaway: MIRA Pharmaceuticals announced positive topline results from its Phase 1 SAD study of Ketamir-2, a next-generation ketamine analog. The study indicated that Ketamir-2 was safe and well tolerated across all dose levels, with no severe adverse effects. Additionally, the drug exhibited rapid absorption and a favorable duration of action, allowing for once-daily dosing.
Price reaction · baseline $1.25 (2025-09-19 close) · hit pre-market · clean, no other MIRA news in the window
day 0 close · peak
+6.4%
day 1
+4%
day 3
+4%

Market Sentiment Analysis

POSITIVE FACTORS

  • Ketamir-2 demonstrated safety and tolerability at all dose levels.
  • The drug showed rapid and predictable absorption.
  • Favorable duration of action supports once-daily dosing.
  • No CNS side effects typically associated with ketamine were observed.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+5%
120-day peak, hindsight
Typical move
0.6%
average across 2 past catalysts
Cash runway
~21 mo
Low dilution risk

Full Press Release Details

Study demonstrated Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption, a favorable duration of action supporting once-daily dosing, and no CNS side effects typically seen with ketamine. MIAMI, FLORIDA / ACCESS Newswire / September 22, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) (“MIRA” or the “Company”), a clin…
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Frequently Asked Questions

What were the results of the Ketamir-2 Phase 1 study?

The Phase 1 study showed that Ketamir-2 was safe and well tolerated at all dose levels.

How does Ketamir-2 compare to traditional ketamine?

Ketamir-2 demonstrated no CNS side effects typically seen with traditional ketamine.

What is the dosing frequency for Ketamir-2?

Ketamir-2 supports once-daily dosing due to its favorable duration of action.

Where is MIRA Pharmaceuticals based?

MIRA Pharmaceuticals is based in Miami, Florida.

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Tags: MIRA Viatris Investor Conferences Healthcare MIRA Pharmaceuticals Ketamir-2 Phase 1 study non-scheduled ketamine safety profile
Last updated: Sep 22, 2025

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Cash runway
$9M liquidity · $0M/mo burn
~21 mo
Low dilution risk

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+5%
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